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Cytokine adsorption in patients with severe COVID-19 pneumonia requiring extracorporeal membrane oxygenation (CYCOV): a single centre, open-label, randomised, controlled trial

Alexander Supady, Enya Weber, Marina Rieder, Achim Lother, Tim Niklaus, Timm Zahn, Franziska Frech,
Sissi M眉ller, Moritz Kuhl, Christoph Benk, Sven Maier, Georg Trummer, Annabelle Fl眉gler, Kirsten Kr眉ger, Asieb Sekandarzad, Peter Stachon, Viviane Zotzmann, Prof Christoph Bode, Paul M Biever, Dawid Staudacher, Tobias Wengenmayer, Erika Graf,
Daniel Duerschmied
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Resumen

Background

We sought to clarify the benefit of cytokine adsorption in patients with COVID-19 supported with venovenous extracorporeal membrane oxygenation (ECMO).

Methods

We did a single-centre, open-label, randomised, controlled trial to investigate cytokine adsorption in adult patients with severe COVID-19 pneumonia requiring ECMO. Patients with COVID-19 selected for ECMO at the Freiburg University Medical Center (Freiburg, Germany) were randomly assigned (1:1) to receive cytokine adsorption using the CytoSorb device or not. Randomisation was computer-generated, allocation was concealed by opaque, sequentially numbered sealed envelopes. The CytoSorb device was incorporated into the ECMO circuit before connection to the patient circuit, replaced every 24 h, and removed after 72 h. The primary endpoint was serum interleukin-6 (IL-6) concentration 72 h after initiation of ECMO analysed by intention to treat. Secondary endpoints included 30-day survival. The trial is registered withClinicalTrials.gov(NCT04324528) and the German Clinical Trials Register (DRKS00021300) and is closed.

Findings

From March 29, 2020, to Dec 29, 2020, of 34 patients assessed for eligibility, 17 (50%) were treated with cytokine adsorption and 17 (50%) without. Median IL-6 decreased from 357路0 pg/mL to 98路6 pg/mL in patients randomly assigned to cytokine adsorption and from 289路0 pg/mL to 112路0 pg/mL in the control group after 72 h. One patient in each group died before 72 h. Adjusted mean log IL-6 concentrations after 72 h were 0路30 higher in the cytokine adsorption group (95% CI 鈭0路70 to 1路30, p=0路54). Survival after 30 days was three (18%) of 17 with cytokine adsorption and 13 (76%) of 17 without cytokine adsorption (p=0路0016).

Interpretation

Early initiation of cytokine adsorption in patients with severe COVID-19 and venovenous ECMO did not reduce serum IL-6 and had a negative effect on survival. Cytokine adsorption should not be used during the first days of ECMO support in COVID-19.
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Publicado en el sitio 2021-05-26 13:27:21

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